International Journal of Pharmaceutical Compounding

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PreScription: Comments on the FDA Guidance "Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry"

Author(s): Allen Loyd V Jr

Issue: Mar/Apr 2022 - Volume 26, Number 2
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Page(s): 92

PreScription: Comments on the FDA Guidance

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Abstract:

Related Keywords: U.S. Food and Drug Administration, FDA, Code of Federal Regulations, FDA Guidance for Industry, Federal Food, Drug, and Cosmetic Act section 503A, drug product, pharmaceutical equivalence, pharmaceutical alternatives, finished dosage form

Related Categories: LEGAL, DOSAGE FORMS/DRUG CARRIERS

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